International Neuromodulation Society Critical Assessment: Guideline Review of Implantable Neurostimulation Devices

Abstract

INTRODUCTION: Spinal cord stimulation (SCS) is well accepted for the treatment of chronic pain since its beginning in 1967. As its use continues to enter into the chronic pain treatment algorithm earlier, conscience patient selection and durability of the therapy are clearly clinically relevant. To improve treatment efficacy, consensus statements and guidelines were developed.

OBJECTIVE: The purpose of this work is to review the relevant guideline statements for implantable neurostimulation therapies to treat chronic pain and to identify guideline gaps and future directions for recommendation platforms.

MATERIALS AND METHODS: A systematic literature search through EMBASE, Medline, Cochrane data base, as well as peer-reviewed, nonindexed journals and materials presented at national and international meetings was performed to chronologically identify consensus statements or guideline statements for use of neurostimulation therapies to treat chronic neuropathic pain limited to the English language.

RESULTS: From 1998 to 2013, 22 guideline statements were identified. Thirteen of the 22 guidelines were society-sponsored guideline statements from ten societies. Two guideline statements were from research foundations, two were government supported, and one statement was published as a position statement.

CONCLUSIONS: The current available guideline statements have clear deficiencies in either scope of coverage, evidence synthesis, or lack of transparency of funding. Improved evidence and best practice/guideline assessment may improve patient outcomes and accessibility to these important modalities. Further prospective comparator randomized data are required to not only provide data of clinical and cost-effectiveness in other indications but also to better describe the position of neurostimulation application within the disease management pathway. Therein cases where there appears to be sufficient evidence and consensus, every effort should be made to secure access to these effective therapies. Importantly, each guideline only has a useful clinical half-life, if not updated. This should be acknowledged by both clinicians and third-party payers. Based on these deficiencies, the International Neuromodulation Society recommended the creation of a consensus conference to examine the appropriate use of neurostimulation for pain and ischemic disease.